Risk Management
Overview
Structured risk management workflow compliant with ISO 14971 and EU MDR requirements.
Available on: All plans
Capabilities
| Module | Description |
|---|---|
| Hazard Identification | Systematic identification of device-related hazards |
| Risk Estimation | Severity and probability assessment |
| Risk Controls | Define control measures |
| Residual Risk | Post-control risk evaluation |
| RCM Traceability | Risk Control Measures traceability matrix |
| Risk Report | Complete risk management documentation |
Workflow
- Hazard Identification -- AI identifies potential hazards based on device type and intended use
- Risk Estimation -- Severity (S1-S5) x Probability (P1-P5) matrix
- Risk Controls -- Design elimination, protective measures, safety information
- Residual Risk -- Acceptability assessment after controls
Risk Matrix
ISO 14971 aligned 5x5 risk matrix (customizable per project):
| P1 | P2 | P3 | P4 | P5 | |
|---|---|---|---|---|---|
| S5 | Low | Medium | High | High | High |
| S4 | Low | Medium | Medium | High | High |
| S3 | Low | Low | Medium | Medium | High |
| S2 | Low | Low | Low | Low | Medium |
| S1 | Low | Low | Low | Low | Low |
Risk levels (Low / Medium / High) are determined by the Severity (S) and Probability (P) combination. The matrix can be customized in the risk management configuration after project creation.
Integration
Risk management data automatically links to:
- GSPR Compliance: Referenced as GSPR 1-3 conformity evidence
- CER: Safety analysis references risk controls
Output Documents
- RCM (Risk Control Measures) traceability matrix
- Risk Management Plan (RMP)
- Risk Management Report (RMR)